With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”

While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?

At this point, no one knows. We are entering into new, uncharted medicolegal territory.

But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.

This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:

Dear Dr. Fisher,

Thank you for your interest in the AliveCor Heart Monitor. I’m writing in response to your tweet to Dr. Dave (Alpert) yesterday. Below are the instructions; in addition these instructions can be found at www.alivecor.com (click on the “Buy Now” link in the upper right corner).

To obtain a monitor for your patients, please follow these steps:

1. Write a prescription for the “AliveCor Heart Monitor for iPhone 4/4S”

3. Go to www.alivecor.com and click on the “Buy Now” link in the upper right to purchase the monitor

a. In the “NPI/State Medical Lic #” enter “Prescription”

NOTE: The patient’s credit card will be charged once they place their order, however we can’t process their order unless we have received their prescription.

Please know that at this time AliveCor does not provide any ECG interpretation, diagnosis or analysis of the data obtained with the monitor. Patients will be instructed to contact you, their physician, regarding any questions they may have regarding their recordings.

Please let me know if you have any questions.

Regards,

It is clear AliveCor wants to provide the device and its app, but will not be responsible for the interpretation of EKG’s. That is up to the doctor and their patient how to manage the clinical expectations of this technology. While some patients could probably perform EKG interpretation basics, I would guess most don’t really understand what that wavy line means. Hence, this is where a discussion should be held with a patient BEFORE prescribing this device and the expectations defined before its use.

For me, I am happy to provide interpretations free of charge when needed as long as it is convenient and non-disruptive to my clinical responsibilities and personal life. There are only so many hours of the day and since I must value that time, cannot bill for this EKG-reading service, and have no quality control over the caliber of the recordings submitted, I consider my interpretations of tracings sent to me to be provided to the patient as a “good Samaritan” in every legal sense of the term. Patients who have clinically worrisome symptoms and need emergent analysis of their heart rhythm should seek help in an emergency department or call 911 and not expect a doctor to provide an immediate interpretation of their tracing, unless such an arrangement is defined clearly between doctor and patient before issuing the device. Expecting a doctor to make urgent clinical decisions based on this single-lead EKG app is of limited utility, in many (and maybe most) instances in my view, so patients should look at this device as a convenient adjunct to more conventional medical care. While it might come one day, the AliveCor iPhone EKG has simply has never been tested for emergency use as of the time of this writing.

So I may do a test run to see how it goes on a test basis but I can already see some legal concerns for doctors who prescribe this device. Until a clear interpretation workflow is established that can provide comprehensive coverage of interpretations paired with a well-defined and easy-to-use interface with a medical record system, patients should understand doctors’ possible hesitation to prescribing this device to a multitude of patients for personal use.

Westby G. Fisher, MD, (aka Dr. Wes) is a board certified internist, cardiologist and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL. He is also a Clinical Associate Professor of Medicine at the University of Chicago’s Pritzker School of Medicine. He blogs at Dr.Wes, where this post originally appeared.

I’m not sure FDA would have had to consider that; the device is not a drug and it is not invasive. I suspect* that the bar was that it provide an accurate EKG tracing and that it not present a risk to the patient.

*I own a couple of small medical device manufacturing companies but they are unrelated to cardiology, so I have some familiarity with FDA positions on devices.

Well you know then but, this is ridiculous idea for the worried well. My golly gosh, they will be taking EKGs incessantly when they worry. Someone has to read them and who will pay. Medicare pays a few dollars, per. Is it wworth it to read 99 normals and one borderline every day?

the heartcheck pen, which is a pocket-sized ecg device (no iphone needed) allows people to pay for their own readings using the free software that comes with the device. The heartcheck pen, unlike the popular app, is FDA cleared for consumer use so you dont need a prescription to buy it.

These devices and all lab testing with the exception of imaging studies should be available to anyone without a prescription. That takes care of the physician liability issue and provides more widely available, convenient and less expensive testing to patients who want to follow their own tests. I do this myself at a lab that allows me to walk in, order the tets and pay cash. Much easier than taking time off work to travel to a lab and pay more money for the same tests. Both sets of labs are run in a certified hospital lab.

The heartcheck pen is a pocket-sized ecg device that is FDA cleared for consumer use, meaning no prescription required to buy it. The company that created the heartcheck pen didnt get the private funding that the app got so you may not have heard of it but it actually does more than the app. Here is a link http://www.theheartcheck.com/products/pen_device.html

The FDA regulates devices differently from medicines, which is to say they dont regulate them at all, except that you must prove your device wont kill anybody.

This is where chiropractors and other sham practitioners make their money. They claim to invent some stupid device like a “robo-spine 2000″ which does absolutely nothing other than show some fancy lights and computer graphics and yet the FDA gives them a green light since it wont kill anybody.

Despite all the hype about the app, there is a device out called the Heartcheck pen. Its a pocket-sized ECG device. It comes with a pay-per-use service that allows patients to transmit their ecg readings online for actual analysis reports from a doctor ($13.99) or ecg tech ($4.99). Alternatively you could use the free software included with the pen to print or email ecgs. Unlike the app, the pen is FDA cleared for consumer use so no prescription needed to buy. Here is a link http://www.theheartcheck.com/products/pen_device.html

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I had cath ablation for atrial fib. Experienced dizziness 6 months later. 3rd degree heartblock showed on my Alivecor device though the previous Holter was unremarkable. I got a pacemaker and doing better except the atrial tachycardias. My outcome has improved with this device. Though being a cardiac surgeon have more understanding when and how to use it. Unfortunately the divide went dead after the warranty wore off. Thanks

Obviously setting up a green screen would be a pain in the arse, so either photoshopping those couple cameras would be less of a hassle, (its only 1 2 3 seconds of frames, if the photoshopping isn’t identical I doubt peoples eyes would be looking at it for artifacts).

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